20 completed. 20 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 20 | Completed 20 |
Follow Congenital Bleeding Disorder: new trials by email Literature Review of Congenital Bleeding Disorder trials Research Report on Congenital Bleeding Disorder
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A Turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 160 | 2018-04-30 | 2022-12-22 |
| Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 68 | 2016-12-12 | 2020-07-27 |
| Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B nonacog beta pegol - Congenital Bleeding Disorder, Haemophilia B | Phase 3 | Completed | Novo Nordisk A/S | 54 | 2014-07-02 | 2025-12-23 |
| Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 124 | 2014-06-26 | 2025-12-23 |
| A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 68 | 2013-02-20 | 2020-11-23 |
| Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 60 | 2012-09-17 | 2020-11-30 |
| Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A. turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 36 | 2012-08-03 | 2020-08-10 |
| Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B nonacog beta pegol - Congenital Bleeding Disorder, Haemophilia B | Phase 3 | Completed | Novo Nordisk A/S | 13 | 2012-06-07 | 2017-08-23 |
| Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B. nonacog beta pegol - Congenital Bleeding Disorder, Haemophilia B | Phase 3 | Completed | Novo Nordisk A/S | 25 | 2012-05-16 | 2025-12-23 |
| Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773 nonacog beta pegol - Congenital Bleeding Disorder, Haemophilia B | Phase 3 | Completed | Novo Nordisk A/S | 71 | 2012-04-15 | 2018-05-09 |
| Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 186 | 2012-01-30 | 2020-11-23 |
| Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors vatreptacog alfa (activated), eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A With Inhibitors | Phase 3 | Completed | Novo Nordisk A/S | 72 | 2011-07-01 | 2017-05-15 |
| Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients nonacog beta pegol - Congenital Bleeding Disorder, Haemophilia B | Phase 3 | Completed | Novo Nordisk A/S | 74 | 2011-04-27 | 2017-07-28 |
| Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency catridecacog - Congenital Bleeding Disorder, Congenital FXIII Deficiency | Phase 3 | Completed | Novo Nordisk A/S | 6 | 2011-01-01 | 2016-06-24 |
| Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency catridecacog - Congenital Bleeding Disorder, Congenital FXIII Deficiency | Phase 3 | Completed | Novo Nordisk A/S | 6 | 2010-11-01 | 2017-02-24 |
| Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 65 | 2010-06-01 | 2017-03-17 |
| Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 214 | 2009-10-26 | 2017-07-27 |
| Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 catridecacog - Congenital Bleeding Disorder, Congenital FXIII Deficiency | Phase 3 | Completed | Novo Nordisk A/S | 63 | 2009-09-21 | 2018-01-24 |
| Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 150 | 2009-04-01 | 2017-03-17 |
| Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency catridecacog - Congenital Bleeding Disorder, Congenital FXIII Deficiency | Phase 3 | Completed | Novo Nordisk A/S | 41 | 2008-08-01 | 2017-02-24 |
Hemophilia A (10) · Hemophilia B (5)
Blood Coagulation Disorders (15) · Blood Coagulation Disorders, Inherited (15) · Coagulation Protein Disorders (15) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (15) · Genetic Diseases, Inborn (15) · Hematologic Diseases (15) · Hemic and Lymphatic Diseases (15) · Hemorrhagic Disorders (15) · Genetic Diseases, X-Linked (5)
nonacog beta pegol (5) · recombinant factor VIII N8 (5) · recombinant factor XIII-A2 (2) · Factor VII (1) · vatreptacog alfa (1)
Novo Nordisk A/S (20)
United States (19) · Italy (16) · Japan (16) · United Kingdom (16) · Malaysia (14) · Germany (13) · Turkey (Türkiye) (13) · France (12) · Israel (12) · Spain (12) · Taiwan (12) · Brazil (10) · Austria (8) · Canada (8) · Greece (8)
PMID 25643920, PMID 25273984, PMID 26679394, PMID 32293786, PMID 22451421, PMID 23647704, PMID 23651313, PMID 23834599, PMID 25263390, PMID 25677761, PMID 26058730, PMID 26970716, PMID 27174727, PMID 27291066, PMID 27352908, PMID 27904904, PMID 28581691, PMID 32369845, PMID 32544297, PMID 32940955, PMID 35858373, PMID 37597724, PMID 37883802
2008 (3), 2009 (2), 2017 (1)